Multiple AvKARE Eye Lubricant Products Recalled Due to Sterility Concerns

The US Food and Drug Administration (FDA) has issued a Class II recall for 5 types of lubricant ophthalmic products—including artificial tears, eye gels, and moisturizing drops—distributed by AvKARE, Pulaski, Tennessee, due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility. The recall involves tens of thousands of cases across multiple lots of products such as Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Gel and Drops, Polyethylene Glycol/Propylene Glycol Lubricant Drops, and Polyvinyl Alcohol Ophthalmic Solution, with expiration dates extending into 2026.

The recalling firm, BRS Analytical Services, LLC, based in St. Louis, Missouri, initiated the voluntary recall on April 23, 2025. The FDA officially classified the recall as Class II on May 6, 2025, indicating that use of these products may cause temporary or medically reversible health effects, with a low risk of serious injury. While no press release has been issued, the recall applies to products distributed nationwide, and pharmacists are urged to identify and remove affected lots, including those under NDCs such as 50268-043-15, 50268-066-15, 50268-068-15, 50268-126-15, and 50268-678-15.

These recalled products are used to relieve dry eye symptoms by lubricating the ocular surface and alleviating irritation caused by wind, screen use, or environmental dryness. Because sterility is critical in ophthalmic solutions to prevent eye infections or corneal damage, any compromise in manufacturing quality poses patient safety risks.